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First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands as Potential PET Radioligands for Imaging Tau Protein in the Brain

NCT07348276 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-16

No results posted yet for this study

Summary

This clinical study is being conducted to learn more about two new imaging drugs, called \[18F\]ABBV-964i and \[18F\]ABBV-965i, which are designed to help doctors see changes in the brain related to a condition called Progressive Supranuclear Palsy (PSP). PSP is a rare disease that affects movement, balance, and thinking. These drugs are used with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called tau builds up. Tau buildup is linked to PSP and other brain diseases.

The main goal of this study is to find out if these imaging drugs are safe for people and if they work well to show tau in the brain. The study will also look at how the drugs move through the body and how much radiation they give off. Researchers hope this information will help develop better tools for diagnosing PSP and tracking how it changes over time.

Who can join? Adults who are healthy or who have PSP may be able to take part. Participants will have screening tests to make sure they qualify.

What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into three parts: Part A checks radiation levels in healthy volunteers, Part B looks at how the drugs work in the brain of PSP patients and healthy volunteers, and Part C (optional) repeats scans to see if results are consistent.

Why is this important? There is currently no cure for PSP, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PSP and similar conditions in the future.

Conditions

  • Progressive Supranuclear Palsy (PSP)
  • Healthy Participants

Interventions

DRUG

[18F]ABBV-965i

PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.

DRUG

Lead Candidate

Preferred PET radiopharmaceuticals (between \[18F\]ABBV-964i and \[18F\]ABBV-965i) selective for tau, administered intravenously at doses up to 10 mCi.

DRUG

[18F]ABBV-964i

PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.

Sponsors & Collaborators

  • Enigma Biomedical USA

    collaborator UNKNOWN

  • Invicro

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348276 on ClinicalTrials.gov